Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers (CBTAC)
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Purpose
The purpose of this study is to determine whether a comprehensive cognitive-behavioral therapy-based, multi-component treatment programme is effective in the treatment of neuropsychiatric symptoms of patients with mild Alzheimer's dementia.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Behavioral: Comprehensive, CBT-based, multi-component treatment Behavioral: Treatment as usual |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial |
- Change from baseline in Geriatric Depression Scale (GDS) [ Time Frame: Pre-treatment, posttreatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
- Change from baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Pre-treatment, post-treatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
- Change from baseline in Bayer-Activities of Daily Living (B-ADL) [ Time Frame: Pre-treatment, post-treatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
- Change from baseline in Stress Coping Inventory (SCI) [ Time Frame: Pre-treatment, post-treatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
- Change from baseline in Apathy Evaluation Scale (AES) [ Time Frame: Pre-treatment, post-treatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
- Caregiver: Change from baseline in Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Pre-treatment, post-treatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
- Caregiver: Change from baseline in Trait scale of the State Trait Anxiety Inventory (STAI) [ Time Frame: Pre-treatment, post-treatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
- Caregiver: Change from baseline in Anger-in and anger-out scales of the State Trait Anger Expression Inventory (STAXI) [ Time Frame: Pre-treatment, post-treatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
- Caregiver: Change from baseline in Short-Form Health Survey (SF-12) [ Time Frame: Pre-treatment, post-treatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
- Caregiver: Change from baseline in Zarit Burden Interview (ZBI) [ Time Frame: Pre-treatment, post-treatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
- Caregiver: Change from baseline in Stress Coping Inventory (SCI) [ Time Frame: Pre-treatment, post-treatment, 6- and 12-months follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 124 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Cognitive Behavioral Therapy (CBT) |
Behavioral: Comprehensive, CBT-based, multi-component treatment
It includes eight modules: diagnosis and goal setting; psychoeducation; engagement in pleasant activities; cognitive restructuring; live review; training caregiver in behavior man-agement techniques; interventions for the caregiver; and couples counselling. It consists of 20 weekly sessions (plus appr. 5 single session with caregiver).
Other Name: Psychosocial intervention
|
| Active Comparator: Treatment as usual (TAU) |
Behavioral: Treatment as usual
Each patient/caregiver must receive at least three out of six interventions: (1) psychoeducation on dementia and treatment of dementia (oral and written); (2) appropriate medical treatment; (3) social counseling by specialized staff; (4) memory training in group setting; (5) self-help group for the patient; (6) self-help group for the caregiver.
Other Name: Standard treatment
|
Detailed Description:
Mild Alzheimer's dementia (AD) cases are with 15 millions worldwide the largest fraction of all AD cases. Most patients are cared for by their family at home. Neuropsychiatric symptoms are very common in AD, even as early as in mild AD: About 90% of all mild AD cases experience neuropsychiatric symptoms, most frequently depression, anxiety, and irritability. These symptoms are associated with greater morbidity, reduced quality of life for the patient, increased burden and depression for the caregiver, higher costs of care, and nursing home placement. Thus, interventions aimed at treating these symptoms could have a tremendous effect on pa-tients, caregivers, and society.
This study is a randomized, controlled trial (RCT) evaluating a comprehensive CBT-based, multi-component treatment programme consisting of eight modules (diagnosis and goal-setting; psycho-education; engagement in pleasant activities; cognitive restructuring; life review; training caregiver in behavior management techniques; interventions for the caregiver; couples counseling) and 20 sessions.
This trial aims at significantly reducing depressive and other neuropsychiatric symptoms in the AD patients, and secondary in reducing burden and depressive symptoms of the caregivers. Patients with AD alone or mixed AD and vascular dementia that are in the mild stage and suffer under any neuropsychiatric symptom will be included. The patients and their caregiver will be randomized to either the CBT-based intervention or to the control condition that receives treatment as usual (TAU).
Eligibility| Ages Eligible for Study: | 50 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients have to meet NINCDS-ADRDA criteria for probable or possible AD (McKhann et al., 1984). Mixed Alzheimer and Vascular dementia cases will also be included.
- Only AD cases with a mild dementia severity will be included, determined by the Clinical Dementia Rating (CDR) scale (i.e. scores of 0.5 or 1, Morris, 1993) and by the Mini Mental State Examination (MMSE) (i.e. scores of 20 or more, Folstein, Folstein, & McHugh, 1975).
- The patient must suffer under any non-cognitive symptom that motivates him to accept psy-chotherapeutic help.
- A caregiver must be available to take part in most of the therapy sessions.
Exclusion Criteria:
- concomitant alcohol or drug addiction and a history of a malignant disease, severe organ failure, metabolic or hematologic disorders, neurosurgery or neurological condition such as Parkinson's disease, epilepsy, postencephalitic and postconcussional syndrome
Contacts and Locations| Contact: Simon Forstmeier, Ph.D. | +41 44 635 73 05 | s.forstmeier@psychologie.uzh.ch |
| Contact: Tanja Roth, Ph.D. | +41 44 389 16 49 | tanja.roth@bli.uzh.ch |
| Switzerland | |
| Psychiatric University Hospital, Clinic for Geriatric Medicine | Recruiting |
| Zurich, Switzerland, 8032 | |
| Contact: Tanja Roth, Ph.D. +41 44 389 16 49 tanja.roth@bli.uzh.ch | |
| Contact: Egemen Savaskan, M.D. +41 44 389 16 58 egemen.savaskan@puk.zh.ch | |
| Principal Investigator: Simon Forstmeier, Ph.D. | |
| Principal Investigator: | Simon Forstmeier, Ph.D. | University of Zurich |
| Study Chair: | Andreas Maercker, M.D.,Ph.D. | University of Zurich |
| Study Chair: | Egemen Savaskan, M.D. | Psychiatric University Hospital, Zurich |
| Study Chair: | Tanja Roth, Ph.D. | Psychiatric University Hospital, Zurich |
More Information
Publications:
| Responsible Party: | Simon Forstmeier, Ph.D., University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01273272 History of Changes |
| Other Study ID Numbers: | 10-130034/1a |
| Study First Received: | January 3, 2011 |
| Last Updated: | October 24, 2011 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University of Zurich:
|
Cognitive Behavior Therapy Early dementia, Alzheimer type |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013